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Human medicine European public assessment report (EPAR): Vafseo (new)
Vadadustat, Renal Insufficiency, Chronic; Anemia
Date of authorisation: 24/04/2023,, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Tibsovo (updated)
Ivosidenib, Leukemia, Myeloid, Acute; Cholangiocarcinoma
Date of authorisation: 04/05/2023,,
, Authorised, Last updated: 12/05/2023
Tibsovo Cancer Adenocarcinoma Neoplasms … Tibsovo is a cancer medicine used to treat adults … with azacitidine (another cancer medicine). The medicine can … -
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Human medicine European public assessment report (EPAR): Bimervax
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023,, Authorised, Last updated: 05/04/2023
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Human medicine European public assessment report (EPAR): Epysqli (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023,,
, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Orkambi (updated)
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015, Revision: 31, Authorised, Last updated: 25/05/2023 -
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Human medicine European public assessment report (EPAR): Opzelura
ruxolitinib phosphate, Vitiligo
Date of authorisation: 19/04/2023, Authorised, Last updated: 20/04/2023 -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Accord
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 15/02/2023,, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Bekemv (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 19/04/2023,, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Plerixafor Accord
Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/12/2022,,
, Authorised, Last updated: 06/02/2023
multiple myeloma (types of blood cancer); children from 1 year of age … has experience in treating cancer or blood disorders. After … multiple myeloma (types of blood cancer); • children from 1 year … -
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Human medicine European public assessment report (EPAR): Sotyktu
Deucravacitinib, Psoriasis
Date of authorisation: 24/03/2023,, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Dapagliflozin Viatris
dapagliflozin, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 24/03/2023,, Authorised, Last updated: 04/04/2023
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Human medicine European public assessment report (EPAR): Dabigatran Etexilate Accord (updated)
Dabigatran etexilate mesilate, Venous Thromboembolism; Arthroplasty, Replacement
Date of authorisation: 26/05/2023,, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Eladynos (updated)
abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis, Revision: 1, Authorised, Last updated: 22/05/2023
osteosarcoma (a type of bone cancer) or in patients who have bone cancer or cancer that has spread to the bones … osteosarcoma (a type of bone cancer) or in patients who have bone cancer or cancer that has spread to the bones … -
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Human medicine European public assessment report (EPAR): Mycapssa
Octreotide acetate, Acromegaly
Date of authorisation: 02/12/2022,, Authorised, Last updated: 22/12/2022
pituitary adenoma (a non-cancerous tumour in the pituitary gland … pituitary adenoma (a non-cancerous tumour in the pituitary … -
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Human medicine European public assessment report (EPAR): Locametz
gozetotide, Radionuclide Imaging
Date of authorisation: 09/12/2022, Revision: 1, Authorised, Last updated: 02/02/2023used in adults with prostate cancer to detect prostate cancer cells with a protein called … find out whether prostate cancer has spread to lymph nodes … find out whether prostate cancer has returned in patients … -
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Human medicine European public assessment report (EPAR): Pluvicto
lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022,, Revision: 2, Authorised, Last updated: 19/04/2023
a medicine used to treat cancer of the prostate (a gland … system). It is used when the cancer is metastatic (spreading … hormone testosterone), and the cancer cells have a protein called … -
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Human medicine European public assessment report (EPAR): Tremelimumab AstraZeneca
Tremelimumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/02/2023,, Authorised, Last updated: 04/04/2023
Neoplasms Thoracic Neoplasms Cancer Neoplasms Lung Diseases Respiratory … Tremelimumab AstraZeneca is a cancer medicine for treating non-small … treating non-small cell lung cancer (NSCLC) that has metastasised … -
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Human medicine European public assessment report (EPAR): Imjudo
Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 20/02/2023,, Authorised, Last updated: 02/03/2023
Glandular and Epithelial Cancer Neoplasms Liver Neoplasms Digestive … Imjudo is a cancer medicine for treating hepatocellular … carcinoma (a type of liver cancer) in patients who have not … -
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Human medicine European public assessment report (EPAR): Hemgenix
Etranacogene dezaparvovec, Hemophilia B
Date of authorisation: 20/02/2023,,
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, Revision: 1, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): VidPrevtyn Beta
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection
Date of authorisation: 10/11/2022,, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Sugammadex Amomed
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 10/01/2023,, Authorised, Last updated: 13/01/2023
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Human medicine European public assessment report (EPAR): Pirfenidone Viatris
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Spevigo
Spesolimab, Psoriasis
Date of authorisation: 09/12/2022,,
, Authorised, Last updated: 08/02/2023
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Human medicine European public assessment report (EPAR): Qdenga
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue
Date of authorisation: 05/12/2022,, Authorised, Last updated: 12/04/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
to treat two types of lung cancer: malignant pleural mesothelioma … malignant pleural mesothelioma (a cancer of the lining of the lungs … chemotherapy before and whose cancer cannot be removed by surgery …